Research Project:
CLINICAL NUTRITION IN CHILDRENTitle: A novel fortified blended flour, corn-soy blend "plus-plus," is not inferior to lipid-based ready-to-use supplementary foods for the treatment of moderate acute malnutrition in Malawian children

Interpretive Summary: Worldwide, approximately 35 million children suffer from moderate acute malnutrition (MAM), and these children have greater susceptibility to infectious disease, delayed cognitive development, and decreased adult stature and productivity. Currently, MAM is treated with fortified blended flours, such as micronutrient-fortified corn-soy blend (CSB), often with recovery rates of less than 75%. Thus, developing improved supplements is critical to improving the lives of these children. In this study a new locally produced CSB fortified with a revised micronutrient mix, dry skim milk, and oil (CSB++, $0.16/serving) was compared to two peanut-based ready-to-use supplementary food formulas, one containing peanut, soy, and micronutrients (locally produced, $0.22/serving), and one containing peanut, soy, dry skim milk, and micronutrients (imported, $0.38/serving). Children treated with the CSB++ recovered at a similar rate to children treated with the peanut supplementary foods. Results indicate that more children may be able to be treated for MAM with the more available and less expensive CSB++. These findings could have a major impact in the treatment of MAM across the globe.

Technical Abstract:
Children with moderate acute malnutrition (MAM) are often treated with fortified blended flours, most commonly a corn-soy blend (CSB). However, recovery rates remain <75%, lower than the rate achieved with peanut-paste-based ready-to-use supplementary foods (RUSFs). To bridge this gap, a novel CSB recipe fortified with oil and dry skim milk, "CSB++," has been developed. In this trial we compared CSB++ with 2 RUSF products for the treatment of MAM to test the hypothesis that the recovery rate achieved with CSB++ will not be >5% worse than that achieved with either RUSF. We conducted a prospective, randomized, investigator-blinded, controlled noninferiority trial involving rural Malawian children aged 6-59 mo with MAM. Children received 75 kcal CSB++ / kg(-1) / d(-1), locally produced soy RUSF, or an imported soy/whey RUSF for 12 wk. The recovery rate for CSB++ (n = 763 of 888; 85.9%) was similar to that for soy RUSF (795 of 806, 87.7%; risk difference: -1.82%; 95% CI: -4.95%, 1.30%) and soy/whey RUSF (807 of 918, 87.9%; risk difference: -1.99%; 95% CI: -5.10%, 1.13%). On average, children who received CSB++ required 2 d longer to recover, and the rate of weight gain was less than that with either RUSF, although height gain was the same among all 3 foods studied. A novel, locally produced, fortified blended flour (CSB++) was not inferior to a locally produced soy RUSF and an imported soy/whey RUSF in facilitating recovery from MAM. The recovery rate observed for CSB++ was higher than that for any other fortified blended flour tested previously.